Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-09-30

Brief Summary

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The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

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Detailed Description

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The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S-488410

Group Type EXPERIMENTAL

S-488410

Intervention Type DRUG

In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).

Interventions

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S-488410

In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).

Intervention Type DRUG

Other Intervention Names

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S-488410 (S-488401, S-488402, S-488403).

Eligibility Criteria

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Inclusion Criteria

* Advanced NSCLC that cannot undergo curative surgery.
* Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
* Histologically diagnosed NSCLC.
* Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
* ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
* Life expectancy \> 3 months.
* Age between 20 to 79
* Male or Female.
* In patients or out patients.
* Able and willing to give valid written informed consent.

Exclusion Criteria

* Other malignancy requiring treatment
* radiation, immunotherapy, hyperthermia, or surgery.
* Active and uncontrolled infectious disease
* Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
* Autoimmune disease.
* HIV-Ab or antigen positive
* Prior anti-cancer therapy within 4 weeks
* Laboratory values as follows: 2000\<mm3 \< WBC \< 15000/mm3, Platelet count \< 50000/mm3, Asparate transaminase \> 5 X cutoff value, Alanine transaminase \> 5 X cutoff value, Total bilirubin \> 3 X cutoff value, and Serum creatinine \> 3X cutoff value.
* Patients knows HLA-A type.
* Breastfeeding and Pregnancy (woman of child bearing potential)
* Refusal of pregnancy conception.
* Treated with S-488401, S-488402, or S-488403.
* Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
* Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No